Human Serum Albumin-Based Topical Ointment for Treatment of Acne, Psoriasis, Egfr-Induced Toxicity, Premature Skin Aging and Other Skin Conditions

ABSTRACT

Dermatological compositions and method for treating psoriasis, eczema, acne and like skin conditions for sanitization pharmaceutical compounding and protection of the skin from extreme environmental conditions are provided which contain serum albumin in an amount effective to treat, reduce the symptoms and improve the appearance of affected skin due to psoriasis, eczema, and acne and like conditions, enhance the delivery performance or stability of pharmaceutical compounding bases, protect the skin from the environment and premature aging, and to lubricate and/or promote the healing of eye after surgical or accidental trauma, when combined with a suitable topical ointment, antibacterial or dermatological agent, pharmaceutical compounding ointment or bases, vehicle, carrier or excipient. The albumin compositions may be in any suitable form for treating skin, such as a cream, oil, lotion, gel, gel-based ointment, and the like. The serum albumin compositions are preferably prepared using recombinant human serum albumin, a truncated version or fragment thereof.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 61/172,461, filed Apr. 24, 2009, incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates in general to the use of a serum albumincomposition to promote health, protective maintenance and treatment of aspectrum of skin conditions including those involving the eye, and morespecifically to the use of human serum albumin, preferably produced byrecombinant means for (1) treatment of psoriasis and eczema; (2)treatment of Acne or Acne related skin conditions, such as those inducedby Epidermal Growth Factor Receptor (EGFR) inhibitors during cancerchemotherapy; (3) use in antiseptic topical aqueous solutions for thepurpose of sanitizing the skin surface for better personal hygiene,surgical preparatory procedures and wound treatment; (4) use inprotecting and fortifying skin against extreme environmental conditions,such as those produced by cold or arid environments, wind, radiationsuch as sun exposure, pollutants and premature aging of the skin; and(5) use as an additive in conventional topical pharmaceuticalcompounding ointments and gel bases to enhance the solubility absorptionand the delivery of active pharmaceuticals.

The albumin-based gel of the invention can be formulated in variousalcohols with additional bactericidal agents which will allow thealbumin to be absorbed in the surface of the skin to enhance the naturalbarrier defense of the skin, while providing maximum penetration for theactive anti-microbial, anti-psoriasis and/or ant-eczema ingredients bydramatically lowering the surface tension of the aqueous solution.Additionally, albumin's inherent small molecule binding properties canbind harmful bacterial fatty acids known to be a factor in certain typesof acne related skin conditions. The albumin can be formulated with orwithout UV blockers in lotions, creams, water and/or alcohol based gels,oils and waxes, which will allow the albumin to be absorbed in thesurface of the skin to effectively enhance the natural defense of theskin against extreme environmental factors, improve the skin barrier andhydration, along with many other inherent natural protective benefits ofalbumin. The albumin can be formulated in lotions and creams, preferablyin water and alcohol based lotions and gels which control the pH andwill allow the albumin to be absorbed in the surface of the skin topromote the delivery of antibacterial agents and other small molecules,while at the same time, enhancing the natural protective defense of theskin against toxic metabolites and pollutants, as a natural component ofthe skin, for the general relief and maintenance of the affected skinareas.

BACKGROUND OF THE INVENTION

The serum albumins belong to a multigene family of proteins thatincludes alpha-fetoprotein and human group-specific component, alsoknown as vitamin-D binding protein. The members of this multigene familyare typically comprised of relatively large multi-domain proteins, andthe serum albumins are the major soluble proteins of the circulatorysystem and contribute to many vital physiological processes. Serumalbumin generally comprises about 50% of the total blood component bydry weight, and as such is responsible for roughly 80% of themaintenance of colloid osmotic blood pressure and is chiefly responsiblefor controlling the physiological pH of blood.

The albumins and their related blood proteins also play an extremelyimportant role in the transport, distribution and metabolism of manyendogenous and exogenous ligands in the human body, including a varietyof chemically diverse molecules including fatty acids, amino acids,steroids, calcium, metals such as copper and zinc, and a plethora ofpharmaceutical agents. The albumin family of molecules are generallythought to facilitate transfer many of these ligands acrossorgan-circulatory interfaces such as the liver, intestines, kidneys andthe brain, and studies have suggested the existence of an albumin cellsurface receptor. See, e.g., Schnitzer et al., P.N.A.S. 85:6773 (1988).The albumins are thus involved in a wide range of circulatory andmetabolic functions.

Human serum albumin (HSA) is a protein of about 66,500 kD protein and iscomprised of 585 amino acids including at least 17 disulphide bridges.As with many of the members of the albumin family, human serum albuminplays an extremely important role in human physiology and is located invirtually every human tissue and bodily secretion. In fact, human serumalbumin is one of the major extracellular proteins of skin, withapproximately 40% of extravascular albumin located in the skin. Further,as indicated above, HSA has an outstanding ability to bind and transporta wide spectrum of ligands throughout the circulatory system includingthe long-chain fatty acids which are otherwise insoluble in circulatingplasma. This same inherent binding and transport function also serves toprotect the body from chemical toxins, such as harmful metabolicproducts (e.g., bilirubin) and various exogenous chemicals, such aspharmaceuticals. The atomic structure and particular details regardingthe binding affinities of albumin and the specific regions primarilyresponsible for those binding properties have been previously determinedas set forth, e.g., in U.S. Ser. No. 08/448,196, filed May 25, 1993, nowU.S. Pat. No. 5,780,594 and U.S. Ser. No. 08/984,176, filed Dec. 3,1997, now U.S. Pat. No. 5,948,609, said applications and patentsincorporated herein by reference.

In the field of eczema, psoriasis, acne and acne related skin disorders;in the field of sanitizing, pre- and post-surgical skin treatment; inthe field of pharmaceutical compounding ointment bases; and in the fieldof extreme environmentally protective lotions, bases and gels, such asthose containing sunscreen; there has been no prior use of humanalbumin, specifically recombinant human albumin, as an active componentof these treatments and formulations. Prior art products have focused onmoisturizers, soap and cleansing agents, anti-wrinkling and othersimilar products which are formulated for cosmetic and skin cleaning.Thus, there is a significant need to develop safe, effective andmarkedly improved skin treatments for the applications and indicationsabove and yet which can be used safely and effectively with a reducedrisk of allergic reactions.

SUMMARY OF THE INVENTION

Accordingly, it is thus an object of the present invention to providenovel skin treating compositions which utilize human serum albumin, andpreferably which comprise recombinant human serum albumin.

It is further an object of the present invention to utilize recombinanthuman serum albumin as a dermatological agent in the treatment ofpsoriasis, eczema and related human skin disorders. It is still furtheran object of the present invention to utilize recombinant human serumalbumin as a dermatological agent in the treatment of acne and acne likeskin disorders such as those induced by cancer chemotherapeuticsincluding, but not limited to those which are EGFR inhibitors, and otherrelated human skin disorders.

It is yet a further an object of the present invention to utilizerecombinant human serum albumin as an additive in skin sanitizationsolutions, such as those used for personal hygiene, professional healthcare, pre and post operative surgical preparation and wound treatmentapplications.

It is still further an object of the present invention to provide acomposition for use in skin applications which are specifically designedto protect the skin from extreme environmental conditions, includingthose which include temperature extremes, low humidity, wind, sunexposure and other forms of radiation, to effectively reduce the risk ofdamaging effects which can accelerate aging (anti-aging) and promotecancer.

It is still further an object of the present invention to provide acomposition for use in eye applications which are specifically designedto lubricate and/or promote the healing of eye after surgical oraccidental trauma. Additionally, the albumin solution may be used as abase for addition of antibiotic or other therapeutic compounds orbiological agents, such as human lysozyme.

It is even further an object of the present invention to provide albumincompositions which can be used as pharmaceutical compounding bases, suchas creams, oils, lotions, gels or gel-based ointments, or any other formthat is suitable for administration to skin which dissolves, delivers,or protects pharmaceutically active ingredients.

These and other objects are achieved by virtue of the present inventionwhich provides a hypoallergenic dermatological compositions forsanitizing and treating the skin for a variety of skin conditionsincluding those of the eye, which comprises serum albumin in an amounteffective to achieve sanitizing or wound protection along with asuitable pharmaceutically acceptable vehicle, carrier or excipient thatis compatible as a sanitizing or wound protective agent. Thehypoallergenic albumin compositions of the invention may be in anysuitable form for treating skin, such as a cream, oil, lotion, gel,gel-based ointment, balm and the like. The serum albumin compositionsare preferably prepared using recombinant serum albumin and are usefulin that they allow the albumin to be absorbed in the surface of skin soas to treat a variety of skin conditions when utilized as a sanitizingor dermatological treatment agent. The compositions of the presentinvention will provide sanitizing or dermatological compositions thatcan be used safely and effectively and with reduced likelihood ofallergic reaction. If considered medically necessary, these compositionsmay be combined with other necessary ingredients such as steroids.

These and other features of the present invention as set forth in, orwill become obvious from the detailed description of the preferredembodiments provided herein below.

BRIEF DESCRIPTION OF THE DRAWING FIGURE

FIG. 1A shows Psoriasis or seborrheic dermatitis prior to treatment withthe albumin alcohol gel; 1B shows Week 4, after treatment appliedliberally once daily. Patient notes skin after treatment is normal,unlike steroid treated skin which left the skin thinner and atypical inappearance. Generally the dermatitis would not return for several weeksif treatment discontinued.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In accordance with the present invention, a skin treating composition isprovided which comprises serum albumin in an amount effective to treat avariety of skin related disorders, or enhanced skin protectionproperties beneficial for extreme environmental conditions. In addition,methods are providing for treating a variety of skin conditions and forprotecting the skin under certain conditions which comprise topicalapplication of the compositions of the present invention in an amountnecessary to treat said condition or to protect the skin in the mannerdescribed herein.

By effective amount is generally meant the amount of serum albumin usedin the composition which will achieve or enhance a beneficial cosmeticor dermatological effect for skin, such as sanitization, treatment of aparticular condition, moisturizing, etc., or would protect skin asdescribed below, as would be readily understood by one skilled in theart. Accordingly, the actual amount of albumin used in the skin treatingor protecting compositions of the present invention will vary greatlydepending on the type of albumin used, the desired effect, and the typeof dermatological agent, pharmaceutical compounding base, vehicle,carrier, excipient, or other suitable sanitizing or treatment base usedin the composition, as would be recognized by one skilled in the art.

For example, in preparing compositions using an alcohol or water gelbase as the carrier, concentrations of albumin preferably range from 1mg/ml to 90 mg/ml of the gel base. However, depending on the specificpurpose of the compositions or solutions of the invention, e.g.,psoriasis treatment, acne treatment, eczema treatment, environmentalprotection, pharmaceutical compounding, etc., the amount of albumin usedmay vary, and can be adjusted based on the desired strength of thecomposition or solution. Accordingly, compositions in accordance withthe invention can be prepared using albumin in concentrations as low asabout 0.01 mg/ml or as high as about 250 mg/ml, which will again dependon the desired application and the nature of the carrier or base intowhich the albumin will be incorporated. Moreover, the albumin solutionscan be prepared at pH conditions which promote the optimal functionalityand stability of albumin, preferably at pH values between 4.5 and 9.0,but more preferably at pH 6.5 to 7.5.

As would also be recognized by one skilled in the art, the creams,lotions and balms used in accordance with the invention for the purposesof topically delivering therapeutics, nutrients, etc. to the skin fortreating psoriasis and other skin disorders or protecting skin, may alsoinclude one or more natural oils. Conventional natural oils and fattyacids include palm oil, flax seed oil, grape seed oil, olive oil, cornoil, cod liver oil, fish oil, safflower seed oil, lemon oil, conjugatedlinoleic acids, palmitic acids and the like. Similarly, certain waxesnatural and man made, could be used to formulate the desired bases.Conventional waxes include but are not limited to Candelilla wax, Soywax, Bees wax, petroleum based wax, petrolatum, lanolin and theCompositions in accordance with the invention may also include importantvitamins like vitamin C, D, A, K and E, or any other vitamins or othersupplements commonly used in skin care products.

Furthermore, the incorporation of gelling agents which can improveproduct presentation and function for a variety of applications may alsobe used in accordance with the invention. Conventional gelling agentsinclude one or more of the following, but are not limited to,hydroxyethylcelluose, carbomer, a polyethylene homopolymer, apolyethylene/vinyl acetate copolymer, a polyethylene/acrylic acidcopolymer, azelaic acid, aloe vera, lecithin, thermoreversiblepolysaccarides, and cetylhydroxyethyl cellulose. Even further, whereappropriate, it may be desired to add one or more UV blocking agents toprotect the skin from UVA and UVB sun damage. These agents include butare not limited to Aminobenzoic acid (PABA), Avobenzone, Cinoxate,Dioxybenzone, Ecamsule (terephthalylidene dicamphor sulfonic acid),Homosalate, Methyl anthranilate, Octocrylene, Octyl methoxycinnamate,Octyl salicylate, Oxybenzone, Padimate O, Phenylbenzimidazole sulfonicacid, Sulisobenzone, Titanium dioxide, Trolamine salicylate, Zinc oxide.Still further, where appropriate, it may be desired to incorporate ananti-microbial such as: Silver sulfaldazine, tetracycline, sulfacetamidesodium/sulfur, bacitracin, polymyxin B, penicillin, amoxicillin,retpamulin, mupirocin, mafenide, sulfamethoxazole, trimethoprim,neomycin, sulfonamide, melocyclin, benzalkoniumchloride, accutane,doxycycline, etc.

Human albumin can be used to treat or enhance treatment of various formsof skin conditions, including psoriasis, eczema, acne, EGRFinhibitor-induced skin toxicities, etc. Vehicles and carriers commonlyused in treating these conditions include, lotions, creams, bases,balms, as well as soaps and shampoos.

Albumin: Theory of Action in Skin Treatment and Sanitization

As indicated above, It has been discussed previously that 40% of thebody's extravascular albumin is located in one organ, the skin. Skincells will not grow optimally in vitro without the presence of albuminin the growth medium. Thus, albumin promotes skin regrowth of healthyskin cells and healing. This property is no doubt imparted by two otherfunctions of albumin, inherent in the circulatory system, control of thepH and binding an transporting an immense variety of nutrients tofacilitate bioavailability (important vitamins, like Vitamin E and fattyacids which are otherwise insoluble). This important binding functionalso serves to protect the body since albumin sequesters foreignmolecules which may be harmful, chemically react with DNA, etc. and inthe case of plasma albumin, off loads them to the liver. In the skin,these bound molecules are captured by albumin (such as bilirubin, theyellow pigment found in the skin during jaundice).

In accordance with the present invention, albumin has been observed topenetrate and absorb into the dermis when applied through a variety oftopical base formulations. Once in the dermis it can hydrate the dermisand also possibly the hypodermis, by osmotic concentration gradienteffects. Once there, it may also contribute to the proper pH balance ofthe skin since this is also one of albumins functions in the circulatorysystem. However, it is important to recognize that the pH of the skin,typically 4.5 to 5.5, is at or near the isoelectric point of albumin(which varies widely depending on the type and quantity of ligandsbound), a pH where albumin is insoluble and thus serving to enhance theskin barrier. An interesting supporting note is that the allergicreaction to pet dander, is to the albumin (ie., dog or cat albumin) inthe dander.

When the albumin solutions are also used in conjunction with bacterialagents, such as ethanol, it is believed that the albumin molecule,surface saturated with ethanol, penetrates the epidermis a releases itsethanol payload or other anti-microbial over time in the dermis. It isalso understood that ethanol contributes to delivery of therapeuticagents into the dermis. The dermis contains the oil sacs and hairfollicles (sebaceous glands) that may be infected with bacteria.Albumin, even in small concentrations dramatically lowers the surfacetension of aqueous solutions, allowing solutions deeper penetrationthrough pores, hair follicles and other cracks and fissures in the skin.As a very large macromolecule, albumins diffusion coefficient is quitelow, so it will reside in localized application areas for days or weeks,whereas, small molecules will diffuse away in a matter of minutes orhours.

Recently in a study by the National Institutes of Health, it wassuggested that the cause of immune responses to certain skin disorderscould be related to atypical bacterial flora, promoted by non-optimumskin pH conditions, etc. See, e.g., Grice et al., Topographical andTemporal Diversity of the Human Skin Microbiom, Science324(5931):1190-1192, May 29, 2009), said article incorporated herein byreference. It is believed that the absorption of albumin has manifoldbenefits to help restore “normal” skin growth to the region, by 1)eliminating harmful bacteria, e.g., ethanol or another anti-microbial(such as clindamycin, peroxide, etc.) with albumin, 2) restoration ofproper pH, nutrient delivery, etc. to skin cells. Skin cells do not growoptimally outside the body except in the presence of albumin. Thistheory has been supported by observations of reductions in psoriasisconditions which last for periods up to 4 weeks, then re-occur. Theinventor has associated this time frame with the slow disappearance ofthe supplemented albumin. Once treatment is resumed, normal skin growthis re-established.

Finally, one of albumin's inherent functions is to sequester harmfulagents, it is therefore a natural protectant from damaging environmentaleffects such as sun damage, cold, heat, wind and exposure to cytotoxicdrugs such as cancer drugs or related toxicities, or other harmfulexposure to toxic endogenous and exogenous ligands. Many of thesecompounds may also contribute to undesirable inflammatory reactions.

Alcohol gel based carriers combined with recombinant human serum albuminhave been used effectively in many cases to treat acne, cancer treatment(e.g., EGRF inhibitor associated skin abnormalities), and psoriasis andeczema types of skin conditions (Example 1).

In the case of another embodiment, referred to herein as albuminsupplemental therapy, the additional albumin can be used to provideadded moisture and barrier protection while at the same time enhancingthe capability of the skin to react with harmful metabolic orenvironmental toxins, an important inherent biological function ofalbumin described above. Moreover, in a related embodiment, the albuminsupplement and/or drug delivery vehicle according to the invention canbe in the form of a topical for use as a sunscreen to aid in theprevention of sunburn and limit the potential damage of free radicals tocause skin damage and potentially cancer, for the delivery of importantnutrients for the normal growth and maintenance of skin.

Other conditions treatable by the albumin supplement and/or drugdelivery vehicle of the invention include insect bites, chapped lips,bedsores and Herpes.

In addition, the albumin gel or lotion of the invention can constitute adrug delivery vehicle in the form of a topical treatment for acne,psoriasis, eczema and a variety of immune related skin disorders. Thealbumin supplement and/or drug delivery vehicle can also be in the formof a topical to promote wound sanitization and healing. If suitable, thealbumin supplement and/or drug delivery vehicle in the form of a topicalfor treatment of a variety of skin disorder/conditions can also containan anti-microbial agents, such as clindamycin, erythromycin,tetracycline, benzoyl peroxide, Silver sulfaldazine, tetracycline,sulfacetamide sodium/sulfur, bacitracin, polymyxin B, penicillin,amoxicillin, retpamulin, mupirocin, mafenide, sulfamethoxazole,trimethoprim, neomycin, sulfonamide, melocyclin, benzalkoniumchloride,accutane, doxycycline, benzoyl peroxide, human lysozyme, hen egg whitelysozyme, chalorapsis lysozyme, acetic acid, ammonia, ethanol, isopropylalcohol, phenoxyethanol, triclocarban, or anti-psoriasis, anti acne oranti eczema agents, such as zinc pyrithione, selenium suphide (seleniumdisulphide), Polylysine episilon, alcohol and salicylic acid or saltsthereof, etc.

In another embodiment of the invention, a pharmaceutical compoundingbase can be prepared by incorporating an effective amount of albumin ina base material commonly used in sanitizing or skin treatingcompositions, e.g., alcohol gels. In a preferred embodiment, a 10-75%alcohol solution, preferably about 65%, containing about 1-90 mg/ml ofrecombinant serum albumin, preferably about 20 mg/ml, can be preparedand employed as a sanitizing solution for personal hygiene, surgicalpreparatory procedures, such as, pre and post operative incisiontreatment. The inventor theorizes that the composition of the inventionwill be useful in providing additional anti-microbial protection due tothe enhanced skin penetration of the albumin mixture.

In the preferred embodiment, the compositions of the present inventioncan be prepared by direct addition of the albumin to the pharmaceuticalbase, dermatological agent or carrier, such as a cream, lotion oralcohol-gel base, and the albumin may be added in any appropriate form,e.g., solid, freeze-dried, liquid etc. With regard to the form ofalbumin useful in the compositions of the present invention, it isparticularly preferred that human serum albumin be employed in thesecompositions, and preferably a recombinant serum albumin is used, suchas those previously disclosed in U.S. Pat. No. 5,780,594 and U.S. Pat.No. 5,948,609, both of which are incorporated herein by reference. Thealbumin used may be in whole form or may be in the form of relevantfragments, such as particular domains, subdomains, etc., including thosethat have been disclosed in the patents referred to above. In addition,a modified or truncated human albumin such as disclosed in U.S. Pat. No.6,787,636, incorporated herein by reference, may also be utilized in theinvention. As set forth therein, the serum albumin may be one that hasat least a one-amino acid truncation at its n-terminal end, or any othermutation at the n-terminal end which is sufficient to cause sterichindrance at the n-terminal end so as to reduce or eliminate thealbumin's affinity to trace metals. Still other forms of albumin mayalso be suitable for certain applications.

Treatment compositions which include serum albumin in accordance withthe invention, or the preferable recombinant human serum albumin, can beeffectively formulated with a wide variety of conventional ingredientscommon to lotions, bases, ointments, creams, balms and the like whichcan comprise the vehicles, excipients or carriers in accordance with theinvention, Example of these ingredients include, but are not limited to:Water, Ppg-15 Stearyl Ether, Oxidized Polyethylene, Stearyl Alcohol,Cetyl Betaine, Salicylic Acid, Distearyldimonium Chloride, Sodium LaurylSulfate, Cetyl Alcohol, Alcohol, Steareth-21, Cyclopentasiloxane,Niacinamide, Ethylene/Acrylic Acid. Copolymer, Dimethicone Crosspolymer,Propylene Glycol, Butylene Glycol, Panthenol, Peg-10 DimethiconeCrosspolymer, Tocopheryl Acetate Cyclopentasiloxane,Polymethylsilsesquioxane, Stearyl Dimethicone, Palmitoyl Pentapeptide-3,Cetearyl Alcohol, Polysorbate 60, Helianthus annuus (sunflower) seedoil, Butyrospermum parkii (shea butter), Neopentyl Glycol Diheptonate,Isododecane, Glycerine, Ricinus communis (castor) seed oil, Hydrogenatedcastor oil, Beeswax, Copernica cerifera (carnauba) wax, Prunus amygdalusdulcis (sweet almond) oil, Caprylic/Capric triglycerides, Lanolin,Cannabis sativa seed oil, Glycine, Conjugated linoleic acid (CLA),Sodium Chloride, Potassium phosphate, Isohexadecane, Petrolatum,Dihydroxyacetone, isopropyl Isostearate, Nylon 12, Aluminum Starch,Octenylsuccinate, Dimethiconol, Hydroxyethyl Acrylate/SodiumAcryloyldimethyl Tauxate Copolymer, Behenyl Alcohol, Erythrulose,Squalane, Benzyl Alcohol, Glyceryl Stearate, PEG 100 Stearate,Dicaprylyl Ether, Sodium Lactate, PEG 40 Stearate, Cyclopentasiloxane,Cyclohexasiloxane, Aluminum Starch, Mineral Oil, Phenoxyethanol,Panthenol, Stearic Acid, Dimethicone, Carbomer, Ceteareth-20, SodiumHydroxide, Sodium. Citrate, Methylparaben, Propylparaben, Citric Acid,Ethylparaben, Glyceryl Stearate SE, Octyldodecanol, Alcohol Denatured,Myristyl Alcohol, Creatine, Ubiquinone, Carbomer, 1 Methylhydantoin 2Imide, C12 15 Alkyl Benzoate, Glyceryl Monostearate, Diazolidinyl,Trolamine, Edetate Disodium, Xanthan Gum, White Petrolatum USP,Ceteareth-20, Malic Acid, Sodium Lactate, Xanthan Gum. NF, C10 30Cholesterol/Lanesterol, Hexyldecanol, Isopropyl Myristate, GlycerylCaprate, Carthamus Tinctorius (Safflower) Seed Oil (Safflower),Styrene/Acrylates Copolymer, PEG 5 Soy Sterol, 1,2 Hexanediol, CaprylylGlycol, Ethylhexylglycerin, Triethanolamine, Grape seed oil, corn nil,coconut oil, olive oil, sodium palmitate, polyethylene (glycols (PEG),Candelilla wax, Soy wax, bees wax, petroleum based wax, Lecithin Gel(PLC) PEG-100 Polydimethylsiloxane, emulsifying wax, cyclomethicone,lemon nil, avocado oil, glycerin, vitamin C, vitamin D, Polylysineepsilon, propylparaben, flax seed oil, cod liver oil, petrolatum, andlanolin.

A general moisturizing lotion that can be utilized in accordance withthe invention is set forth as follows:

Classification and Ingredients Information: INCI Names: CAS Nos.: RangeIngredient: Water 7732-18-5  >30% to 100% Cetearyl Alcohol 8005-44-5 >3% to 10% Polysorbate 60 9005-67-8  >3% to 10% Caprylic/caprictriglycerides 8001-31-8 >1% to 3% Helianthus annuus (sunflower)8001-21-6 >1% to 3% seed oil Butyrospermum parkii (shea 68920-03-6 >1%to 3% butter) Neopentyl Glycol Diheptonate 68855-18-5 >1% to 3%Isododecane 13475-82-6 >1% to 3% Glycerine 56-81-5 >1% to 3% PrunusAmygoalus Dulcis (Sweet 8007-69-0 >1% to 3% Almond) Oil Vitis vinifera(grape) seed oil 8024-22-4 >1% to 3% Tritcum vilgare (wheat germ)68917-73-7 >1% to 3% Glycol Stearate 111-60-4 >1% to 3% Theobroma cacoa(cocoa) seed 8002-31-1 >0.3% to 1%   butter Tocopheryl acetate (vitaminE) 58-95-7 >0.3% to 1%   Phenoxyethanol 122-99-6 >0.3% to 1%  Acrylates/C10-30 Alkyl Acrylate 1310-73-2 >0.1% to 0.3% CrosspolymerSodium Hydroxide >0.1% to 0.3%

A general lip or body balm that can be utilized in accordance with theinvention is set forth as follows:

Classification and Ingredients Information: INCI Names: CAS Nos.: RangeIngredient: Ricinus communis (castor) seed 8001-79-4 oil & Hydrogenatedcastor oil & 8001-79-4 Beeswax & 8012-89-3 Copernica cerifera (carnauba)8015-86-9 >30% to 100% wax Prunus amygdalus dulcis (sweet 8007-68-0 >3%to 10% almond) oil Caprylic/Capric triglycerides 8001-31-8 >1% to 3% Lanolin 8006-54-0 >0.3% to 1%   Tocopherol acetate 58-95-7 >0.3% to 1%  Cannabis sativa seed oil — 0.1% or less

The present invention also contemplates the use of serum albumin as asub or UV-blocking composition. A general list of ingredients that canbe used as blocking agents along with albumin in accordance with theinvention is set forth as follows:

Sunscreen Ultra Violet Radiation FDA Approved Blocking Agents

Classification and Ingredients Information: Names: CAS Nos.: RangeIngredient: Aminobenzoic acid (PABA) — > to 15% Avobenzone > to 3% Cinoxate > to 3%  Dioxybenzone > to 3%  Ecamsule (terephthalylidene > to10% dicamphor sulfonic acid) Homosalate > to 15% Methyl anthranilate >to 5%  Octocrylene > to 10% Octyl methoxycinnamate  > to 7.5% Octylsalicylate > to 5%  Oxybenzone > to 6%  Padimate O > to 8% Phenylbenzimidazole sulfonic acid > to 4%  Sulisobenzone > to 10%Titanuim dioxide > to 25% Trolamine salicylate > to 12% Zinc oxide > to25%

Other sets of ingredient that can be utilized as the vehicle, excipientor carrier, or ingredients thereof, in accordance with the presentinvention, are as follows:

Water, Glycerin, Isohexadecane, Petrolatum, Dihydroxyacetone, IsopropylIsostearate, Nylon 12, Aluminum Starch Octenylsuccinate, Dimethicone,Dimethiconol, Stearyl Alcohol, Hydroxyethyl Acrylate/SodiumAcryloyldimethyl Taurate Copolymer, Cetearyl Alcohol, Behenyl Alcohol,Erythrulose, Squalane, Benzyl Alcohol, Tocopheryl Acetate, GlycerylStearate, PEG 100 Stearate, Xanthan Gum, Disodium EDTA, Ethylparaben,Methylparaben, Propylparaben, Capric/Caprylic Stearic Triglyceride,Polysorbate 60, Fragrance (Parfum), Red 33, Yellow 5Water, Glycerin, Urea, Glyceryl Stearate, Stearyl Alcohol, DicaprylylEther, Sodium Lactate, Dimethicone, PEG 40 Stearate, Cyclopentasiloxane,Cyclohexasiloxane, Aluminum Starch. Octenylsuccinate, Lactic Acid,Xanthan Gum, Phenoxyethanol, Methylparaben, PropylparabenWater, Mineral Oil, Glycerin, Capric/Caprylic Stearic Triglyceride,Cetearyl Alcohol, Phenoxyethanol, Panthenol, Cetearyl Alcohol, StearicAcid, Dimethicone, Carbomer, Ceteareth-20, Sodium Hydroxide, SodiumCitrate, Methylparaben, Propylparaben, Citric Acid, EthylparabenWater, Glycerin, Mineral Oil, Glyceryl Stearate SE, Octyldodecanol,Alcohol Denatured, Stearic Acid, Dicaprylyl Ether, Dimethicone, MyristylAlcohol, Creatine, Ubiquinone, Phenoxyethanol, Fragrance (Parfum),Carbomer, Sodium Hydroxide, 1 Methylhydantoin 2 Imide, Methylparaben,Propylparaben

Active Ingredients: Octinoxate (7.5%) (Sunscreen), Octisalate (4%)(Sunscreen), Oxybenzone (3%) (Sunscreen)

Inactive Ingredients: Water Purified, C12 15 Alkyl Benzoate, CetearylAlcohol, Ceteareth 20, Cetearyl Alcohol, Glyceryl Monostearate,Propylene Glycol, White Petrolatum, Diazolidinyl Urea, Trolamine,Edetate Disodium, Xanthan Gum, Acrylates/C10 30 Alkyl AcrylateCrosspolymer, Vitamin E, Iodopropynyl Butylcarbamate, Fragrance(Parfum), CarbomerWater USP (Purified), Glycerin USP, White Petrolatum USP, CetearylAlcohol (and), Ceteareth-20, Malic Acid, Sodium Lactate, Xanthan Gum NF,Dimethicone, C10 30 Cholesterol/Lanesterol Esters, Sodium Hydroxide NF,Cetyl Alcohol NF, Diazolidinyl Urea, Methylparaben, Cetyl Lactate, C1215 Alcohols Lactate, Propylparaben NF, Cyclomethicone, Sodium PCA,Fragrance (Parfum)

Active Ingredients: Homosalate (6%, Sunscreen), Octisalate (5%,Sunscreen), Avobenzone (3%, Sunscreen), Oxybenzone (3%, Sunscreen),Octocrylene (2.4%, Sunscreen)

Inactive Ingredients: Water, Hexyldecanol, Propylene Glycol, StearicAcid, Isopropyl Myristate, Glyceryl Caprate, Glyceryl Stearate, PEG 100Stearate, Cetearyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil(Safflower), Styrene/Acrylates Copolymer, PEG 5 Soy Sterol, 1,2Hexanediol, Caprylyl Glycol, Ethylhexylglycerin, Dimethicone,Phenoxyethanol, Triethanolamine, Acrylates C10 30 Alkyl AcrylateCrosspolymer, Tetrasodium EDTA, Xanthan Gum, Soluble Collagen, Kinetin,Panthenol, Ascorbic Acid (Vitamin C), Hydrolyzed ElastinWater, Glycerin, Stearyl Alcohol, Glyceryl Stearate, PEG 100 Stearate,Carthamus Tinctorius (Safflower) Seed Oil (Safflower), EthylhexylHydroxystearate, Cetearyl Alcohol, Acrylates C10 30 Alkyl AcrylateCrosspolymer, Dimethicone, Panthenol, Glycine Soja Sterol (Soybean),Sodium Hydroxide, Kinetin, Aloe (Aloe Barbadensis) Leaf Juice,Tocopheryl Acetate, Ascorbic Acid (Vitamin C), Zea Mays Oil (Corn),Retinyl Palmitate, Cholecalciferol (Vitamin D3), Diazolidinyl Urea,Citric Acid, Methylparaben, PropylparabenWater, Ppg-15 Stearyl Ether, Glycerin, Oxidized. Polyethylene, StearylAlcohol, Cetyl Betaine, Salicylic Acid, Distearyldimonium Chloride,Sodium. Lauryl Sulfate, Cetyl Alcohol, Alcohol, Steareth-21, SodiumChloride, Behenyl Alcohol, Ppg-30, Steareth-2, Sodium Glycolate,Panthenol, Tocopheryl Acetate, Carnosine, Disodium Edta, AscorbicAcid++, Fragrance, Iron Oxides.Water, Cyclopentasiloxane, Glycerin, Niacinamide, Ethylene/Acrylic AcidCopolymer, Dimethicone, Dimethicone Crosspolymer, Propylene Glycol,Butylene Glycol, Panthenol, Peg-10 Dimethicone Crosspolymer, TocopherylAcetate, Palmitoyl Pentapeptide-3+, Sucrose Polycottonseedate, StearylDimethicone, Titanium Dioxide, Bis-Peg/Ppg-14/14 Dimethicone BenzylAlcohol, Peg-10 Dimethicone, Cetyl Ricinoleate, Allantoin, Carnosine+,Disodium Edta, Camellia Sinensis Leaf Extract, Peg-100 Stearate,Alumina, Citric Acid, Peg/Ppg-18/18 Dimethicone, Ethylparaben,Propylparaben, Methylparaben, Fragrance, Yellow 5, Red 40.

Cyclopentasiloxane, Water, Glycerin, Polymethylsilsesquioxane,Dimethicone, Niacinamide, Dimethicone Crosspolymer, Stearyl Dimethicone,Butylene Glycol, Panthenol, Propylene Glycol, Palmitoyl Pentapeptide-3,Tocopheryl Acetate, Camellia Sinensis Leaf Extract, Cucumis Sativus(Cucumber) Fruit Extract, Allantoin, Petrolatum, Cetyl Ricinoleate,Peg-10 Dimethicone Crosspolymer, Sucrose Polycottonseedate,Bis-Peg/Ppg-14/14 Dimethicone, Benzyl Alcohol, Peg-10 Dimethicone,Peg-100 Stearate, Ethylparaben, Methylparaben, Propylparaben, DisodiumEdta, Triethoxycaprylylsilane, Mica, Titanium Dioxide, Iron Oxides.

As indicated above, the skin and hair treating albumin compositions ofthe present invention may take on a variety of forms which may besuitable for use as a skin treatment or dermatological agent. Suchembodiments would include oils, moisturizing cream, hand lotions,shaving creams, gels, gel-based ointments, balms or any otherapplication where the goal is treatment, sanitization or protectiveconditioning of skin. These forms are all well known in the art, as iswell known the many conventional methods of preparing thesedermatological forms which could be utilized to prepare thedermatological treating or protecting compositions in accordance withthe invention which contain an effective amount of serum albumin,preferably in recombinant form. Again, all of these skin treatment formsin accordance with the invention will be comprised of an effectiveamount of albumin in a suitable base, i.e., an amount effective toachieve a desired treatment, sanitization, or protective dermatologicalpurpose, as would be appropriate for the desired sanitary conditioning,skin treatment or other dermatological application.

In addition, in accordance with the present invention, the albumincompositions of the present invention may also be utilized to promotesanitization of skin to for personal hygiene, pre and post operativepreparations and procedures, and other forms of hospital associated skinapplications including, the treatment of surgical incision, surfacewounds, etc., but not limited to the treatment of bedsores, and thus mayalso be used in sterile form for treating such conditions.

The advantages of the present invention are exemplified in that thesanitization, treatment of acne, psoriasis, eczema etc. using thesealbumin compositions and formulations will be enhanced and superior toformulations which do not include albumin because the compositions ofthe invention will allow for superior treatment of skin using thelargest single natural extracellular protein component, namely serumalbumin. In addition, these compositions are highly desirable becauseserum albumin, particularly human serum albumin, may be produced byrecombinant methods so as to be extremely safe in that it is non-bloodderived and thus free of animal-derived pathogens. Moreover, thepresence of serum albumin in aqueous solutions dramatically lowers thesurface tension of the aqueous phase, allowing albumin and itsassociated molecules to penetrate the skin in crevices, pores where themajority of bacteria, fungi or other microbial agents are located, etc.to enhance the treatment or sanitization potential of the albumincontaining composition. The preferred compositions of the presentinvention will also be hypoallergenic so as to reduce or eliminate thepossibility of causing an allergic reaction upon application of thecompositions.

The compositions of the present invention can thus be made simply andinexpensively using conventional ingredients and methods currently usedin the conventional preparation of skin protection agents, skintreatments or other dermatological products such as gels, lotions, balmsor pharmaceutical compounding bases and the like. As indicated above, inthe desired process, the albumin may be added directly to the desireddermatological base, such as by dissolving the serum albumin in atreatment base when it is desired to prepare a composition in accordancewith the invention. However, as would be well known to those skilled inthis art, there are numerous conventional processes that may be used toprepare the desired dermatological or pharmaceutical compounding agent,and any suitable variety of these techniques may be employed to preparethe desired compositions in accordance with the invention.

Similarly, the present compositions will be useful in a variety ofdermatological purposes and the use of these forms of the invention willbe by topical application in the conventional manner for the use ofthese products. The products obtained using the albumin compositions ofthe present invention will be superior to conventional treatment,protection, sanitization or moisturizing products in that they will havean enhanced treatment effect due to the use of the albumin.

In yet another embodiment, an albumin solution from 0.01 to 100 mg/ml isprovided comprising a suitable eye solution, such as phosphate bufferedsaline as a base in the form of a topical solution for treatment of dryeye, lasik or other eye surgery, dry socket syndrome, promotion ofhealing involved with surgical or accidental trauma. Additionally, thealbumin solution may be used as a base for addition of antibiotic orother therapeutic compounds or biological agents.

Accordingly, the compositions of the present invention can be used tocreate a wide variety of safe and effective pharmaceutical and otherdermatological products which have superior qualities when used to treata variety of skin disorders, protective or sanitization functions. Inaddition, the compositions will be hypoallergenic and thus will reduceor eliminate the likelihood of causing an allergic reaction when used.

It is thus submitted that the foregoing embodiments are onlyillustrative of the claimed invention and not limiting of the inventionin any way, and alternative embodiments that would be obvious to oneskilled in the art not specifically set forth above also fall within thescope of the claims.

In addition, the following examples are presented as illustrative of theclaimed invention, and are not deemed to be limiting of the scope of theinvention, as defined by the claims appended hereto, in any manner.

EXAMPLES Example 1

Compositions in accordance with the present invention were prepared bydissolving various concentrations of recombinant human serum albumin inan inexpensive conventional lotion or gel base. These compositions wereprepared by the direct addition of from 1 mg/ml to 90 mg/ml (20 mg/mlused in the clinical studies below) of recombinant human albumin infreeze-dried dissolved with gentle mixing in the alcohol gel base.

An Alcohol-based Gel Classification and Ingredients Information: INCINames: CAS Nos.: Range Ingredient: De-ionized and purified Water7732-18-5 >30% to 95% SD Alcohol  >5% to 90% Propylene Glycol  >0% to10% Tocopheryl acetate (vitamin E) >0% to 3% Phenoxyethanol >0% to 3%Hydroxyethylcellulose NF >0% to 3% Sodium Hydroxide >0% to 1%Experimental use of this albumin alcohol gel was made in three separatehuman clinical studies focused on acne, EGFR inhibitor induced cutaneoustoxicities.Clinical Study Cutaneous Toxicities Associated with Epidermal GrowthFactor InhibitorsPhase II pilot study to assess the potential for topical human albuminto modulate the cutaneous toxicities associated with epidermal growthfactor inhibitors in clinical practice.

A. Study Design

The study is designed as a pilot investigation entering up to 15patients who have experienced cutaneous toxicity with epidermal growthfactor inhibitors. These patients will then be consented, offered humanalbumin topically to apply one area of involvement for approximately twoto four weeks and then extended to other areas if they have experiencedsignificant relief of symptoms or improvement of the rash.

The patients will be assessed for efficacy and toxicity every two weeksduring the first six weeks, photographs of each area taken and comparedwith the untreated area so each patient will serve as their own control.

At the completion of the study, each patient will be offered up toanother four weeks of study medication for topical self administration.

B. Results

A total of 15 patients were enrolled in the study. Of these patients,one was removed from the study after the first week, based on theperception that the skin condition was worsening (it should be notedthat this patient was on a dosing level of EGRF inhibitor at more thantwice the other patients). Approximately 40% patients stated that theapplication of the gel was improving their condition, of these, threepatients (or 21%) made extremely favorable statements of markedimprovement (one of these patients had been treated several yearsearlier and remarked on a definite improvement over his previousexperience with EGRF related acne). The remaining patients stated theyobserved no improvement or were noncompliant.

Example 2 Clinical Study: Psoriasis or Dermatitis

Exploratory studies on the treatment of psoriasis were conducted withone patient over the course of two years. The most effective treatmentwas achieved with albumin formulated in an alcohol base as given inEXAMPLE 1.

Results:

The patient's psoriasis affected areas were treated once daily with analcohol base containing 20 mg/ml of recombinant human serum albumin.After day 3, the skin areas began crusting and scaling off, giving theappearance that the condition was worsening. This scaling was followedby the appearance of new skin which over the course of 3 weeks revertedto normal appearance (see FIG. 1). The condition would either 1) beginto re-appear after 2 to 4 weeks, if left untreated, or not return forseveral months.The results were repeated with the same results on as series ofexperiments over the course of two years.

Example 3 Clinical Study: Acne

A total of approximately 50 patients exhibiting various forms of acne oracne-like skin conditions were supplied with 40 ml tubes of the albuminalcohol gel as described in EXAMPLE 1 and followed up with after a blankweek period. Based on anecdotal evidence from patient surveysapproximately 50% of the patients expressed improvement and interest inobtaining a continuing supply. Approximately 10% expressed markedimprovement. Approximately 50% stated they observed no or littleimprovement.

Example 4

Recombinant human serum albumin was added to the lotion base describedbelow at 10 mg/ml. Experimental use of the compositions of the presentinvention was made with numerous individuals who used this lotion asapplied to the hands for the treatment of very dry skin. All of theparticipants noted an immediate and distinctive difference in thetexture and softness of the skin after drying their hands. Allindividuals noted a unique moisturizing and conditioning effect on theskin, without feeling the presence of an oil or grease residue. Thefollowing lotion base was used successfully as an example.

General moisturizing lotion: Classification and Ingredients Information:INCI Names: CAS Nos.: Range Ingredient: Water 7732-18-5  >30% to 100%Cetearyl Alcohol 8005-44-5  >3% to 10% Polysorbate 60 9005-67-8  >3% to10% Caprylic/capric triglycerides 8001-31-8 >1% to 3% Helianthus annuus(sunflower) 8001-21-6 >1% to 3% seed oil Butyrospermum parkii (shea68920-03-6 >1% to 3% butter) Neopentyl Glycol Diheptonate 68855-18-5 >1%to 3% Isododecane 13475-82-6 >1% to 3% Glycerine 56-81-5 >1% to 3%Prunus Amygoalus Dulcis (Sweet 8007-69-0 >1% to 3% Almond) Oil Vitisvinifera (grape) seed oil 8024-22-4 >1% to 3% Tritcum vilgare (wheatgerm) 68917-73-7 >1% to 3% Glycol Stearate 111-60-4 >1% to 3% Theobromacacoa (cocoa) seed 8002-31-1 >0.3% to 1%   butter Tocopheryl acetate(vitamin E) 58-95-7 >0.3% to 1%   Phenoxyethanol 122-99-6 >0.3% to 1%  Acrylates/C10-30 Alkyl Acrylate 1310-73-2 >0.1% to 0.3% CrosspolymerSodium Hydroxide >0.1% to 0.3%

Example 5

Recombinant human serum albumin was added to the lotion base describedbelow at 5 mg/ml. Experimental use of the compositions of the presentinvention was made with numerous individuals who used this lotion asapplied to the hands for the treatment of very dry skin. All of theparticipants noted an immediate and distinctive difference in thetexture and softness of the skin after drying their hands. Allindividuals noted a unique moisturizing and conditioning effect on theskin, without feeling the presence of an oil or grease residue. Thefollowing lotion base was used successfully as an example.

Classification and Ingredients Information: INCI Names: CAS Nos.: RangeIngredient: Water 7732-18-5  >30% to 100% Cetearyl Alcohol 8005-44-5 >3% to 10% Polysorbate 60 9005-67-8  >3% to 10% Caprylic/caprictriglycerides 8001-31-8 >1% to 3% Helianthus annuus (sunflower)8001-21-6 >1% to 3% seed oil Butyrospermum parkii (shea 68920-03-6 >1%to 3% butter) Neopentyl Glycol Diheptonate 68855-18-5 >1% to 3%Isododecane 13475-82-6 >1% to 3% Glycerine 56-81-5 >1% to 3% PrunusAmygoalus Dulcis (Sweet 8007-69-0 >1% to 3% Almond) Oil Vitis vinifera(grape) seed oil 8024-22-4 >1% to 3% Tritcum vilgare (wheat germ)68917-73-7 >1% to 3% Glycol Stearate 111-60-4 >1% to 3% Theobroma cacoa(cocoa) seed 8002-31-1 >0.3% to 1%   butter Tocopheryl acetate (vitaminE) 58-95-7 >0.3% to 1%   Phenoxyethanol 122-99-6 >0.3% to 1%  Acrylates/C10-30 Alkyl Acrylate 1310-73-2 >0.1% to 0.3% CrosspolymerSodium Hydroxide >0.1% to 0.3%

Example 6

Recombinant human serum albumin was added to the lip balm base describedbelow at 1 mg/ml. Experimental use of the compositions of the presentinvention was made with numerous individuals who used the lip balm forthe treatment of chapped lips on individuals who frequently use lipbalm. All of the participants noted a long lasting protective effectwhich was perceived as an important improvement over conventional lipbalm.

A lip or body balm Classification and Ingredients Information: INCINames: CAS Nos.: Range Ingredient: Ricinus communis (castor) seed8001-79-4 oil & Hydrogenated castor oil & 8001-79-4 Beeswax & 8012-89-3Copernica cerifera (carnauba) 8015-86-9 >30% to 100% wax Prunusamygdalus dulcis (sweet 8007-68-0 >3% to 10% almond) oil Caprylic/Caprictriglycerides 8001-31-8 >1% to 3%  Lanolin 8006-54-0 >0.3% to 1%  Tocopherol acetate 58-95-7 >0.3% to 1%   Cannabis sativa seed oil — 0.1%or less

1. A skin treatment composition comprising human serum albumin in anamount effective to treat a skin or scalp condition selected from thegroup consisting of psoriasis, eczema, acne, EGRF inhibitor relatedcutaneous skin toxicities and a suitable aqueous or alcohol-based gel,or suitable topical ointment and a pharmaceutically acceptable vehicle,carrier or excipient.
 2. The composition according to claim 1 whereinthe serum albumin comprises a recombinant serum albumin.
 3. Thecomposition according to claim 1 wherein the serum albumin comprises aserum albumin that has at least a one-amino acid truncation at itsn-terminal end.
 4. The composition of claim 1 wherein the vehicle,excipient or carrier is selected from the group consisting of creams,balms, lotions, gels, and ointments effective for the treatment of thetargeted skin areas.
 5. The composition of claim 4 wherein said vehicle,excipient or carrier includes an ingredient selected from the groupconsisting of: Water, Ppg-15 Stearyl Ether, Oxidized Polyethylene,Stearyl Alcohol, Cetyl Betaine, Salicylic Acid, DistearyldimoniumChloride, Sodium Lauryl Sulfate, Cetyl Alcohol, Alcohol, Steareth-21,Cyclopentasiloxane, Niacinamide, Ethylene/Acrylic Acid Copolymer,Dimethicone Crosspolymer, Propylene Glycol, Butylene Glycol, Panthenol,Peg-10 Dimethicone Crosspolymer, Tocopheryl Acetate Cyclopentasiloxane,Polymethylsilsesquioxane, Stearyl Dimethicone, Palmitoyl Pentapeptide-3,Cetearyl Alcohol, Polysorbate 60, Helianthus annuus (sunflower) seedoil, Butyrospermum parkii (shea butter), Neopentyl Glycol Diheptonate,Isododecane, Glycerine, Ricinus communis (castor) seed oil, Hydrogenatedcastor oil, Beeswax, Copernica cerifera (carnauba) wax, Prunus amygdalusdulcis (sweet almond) oil, Caprylic/Capric triglycerides, Lanolin,Cannabis sativa seed oil, Glycine, Conjugated linoleic acid (CLA),Sodium Chloride, Potassium phosphate, Isohexadecane, Petrolatum,Dihydroxyacetone, Isopropyl Isostearate, Nylon 12, Aluminum StarchOctenylsuccinate, Dimethiconol, Hydroxyethyl Acrylate/Sodium A′ TaurateCopolymer, Behenyl Alcohol, Erythrulose, Squalane, Benzyl Alcohol,Glyceryl Stearate, PEG 100 Stearate, Dicaprylyl Ether, Sodium Lactate,PEG 40 Stearate, Cyclopentasiloxane, Cyclohexasiloxane, Aluminum Starch,Mineral Oil, Phenoxyethanol, Panthenol, Stearic Acid, Dimethicone,Carbomer, Ceteareth-20, Sodium Hydroxide, Sodium Citrate, Methylparaben,Propylparaben, Citric Acid, Ethylparaben Glyceryl Stearate SE,Octyldodecanol, Alcohol Denatured, Myristyl Alcohol, Creatine,Ubiquinone, Carbomer, 1 Methylhydantoin 2 Imide, C12 15 Alkyl Benzoate,Glyceryl Monostearate, Diazolidinyl, Trolamine, Edetate Disodium,Xanthan Gum, White Petrolatum USP, Ceteareth-20, Malic Acid, SodiumLactate, Xanthan Gum NF, C10 30 Cholesterol/Lanesterol, EDTA,Hexyldecanol, Isopropyl Myristate, Glyceryl Caprate, CarthamusTinctorius (Safflower) Seed Oil (Safflower), Styrene/AcrylatesCopolymer, PEG 5 Soy Sterol, 1,2 Hexanediol, Caprylyl Glycol,Ethylhexylglycerin, Triethanolamine, Grape seed oil, corn oil, coconutoil, olive oil, sodium palmitate, polyethylene glycols (PEG), Candelillawax, Soy wax, Lecithin Gel(PLO), PEG-100 Polydimethylsiloxane,emulsifying wax, cyclomethicone, lemon oil, avocado oil, glycerin,vitamin C, vitamin D, Polylysine episilon, propylparaben, and flax seedoil
 6. The skin treatment composition according to claim 1 comprisinghuman serum albumin and one or more gelling agents.
 7. The compositionof claim 6 wherein the gelling agent is selected from the groupconsisting of hydroxyethylcelluose, carbomer, a polyethylenehomopolymer, a polyethylene/vinyl acetate copolymer, apolyethylene/acrylic acid copolymer, azelaic acid, aloe vera, lecithin,thermoreversible polysaccarides, and cetylhydroxyethyl cellulose.
 8. Thecomposition according to claim 1 wherein the serum albumin comprises 1to 100 mg/ml of a gel or solution comprised principally of water and/oralcohol.
 9. The composition according to claim 8 wherein the alcohol orwater-based gel or solution is from 1 to 90%.
 10. The compositionaccording to claim 9 wherein the serum albumin in the alcoholwater-based gel or solution is at a concentration in the range of about1 to 250 mg/ml.
 11. The composition according to claim 2 whereinrecombinant serum albumin is added to solution containing at leastwater, Cetearyl Alcohol and Polysorbate
 60. 12. A method of treating askin condition selected from the group consisting of psoriasis, eczemaand acne comprising topically applying to the skin or scalp of a patientin need thereof the composition of claim 1 in an amount effective totreat said condition.
 13. The skin treatment composition according toclaim 1 comprising 1-90 mg/ml human serum albumin in a 1-90% alcoholsolution.
 14. A hypoallergenic skin treating composition for psoriasiseczema, or acne treatment comprising 1 to 90 mg/ml recombinant humanserum albumin in a 1 to 90% alcohol gel or solution.
 15. Ahypoallergenic skin or scalp treating composition comprising 1 to 90mg/ml of a modified human serum albumin that has at least one mutationat its n-terminal end sufficient to cause steric hindrance at thebinding region VI and thereby reduce or eliminate the albumin's affinityto trace metals, and a suitable vehicle, excipient or carrier.
 16. Thehypoallergenic skin or scalp treating composition according to claim 15wherein the vehicle, excipient or carrier comprises a 1-90% alcoholsolution.
 17. The skin treatment composition according to claim 1wherein the pH is in a range from 4.5 to 9.0.
 18. The skin treatmentcomposition according to claim 1 further comprising an anti-microbialagent.
 19. The composition of claim 18 wherein the anti-microbial isselected from the group consisting of clindamycin, erythromycin,tetracycline, benzoyl peroxide, Silver sulfaldazine, tetracycline,sulfacetamide sodium/sulfur, bacitracin, polymyxin B, penicillin,amoxicillin, retpamulin, mupirocin, mafenide, sulfamethoxazole,trimethoprim, neomycin, sulfonamide, melocyclin, benzalkoniumchloride,accutane, doxycycline, clindamycin, tetracycline, erythromycin, benzoylperoxide, human lysozyme, hen egg white lysozyme, chalorapsis lysozyme,acetic acid, ammonia, ethanol, isopropyl alcohol, phenoxyethanol, andtriclocarban.
 20. The skin treatment composition according to claim 1comprising human serum albumin and anti-psoriasis, anti-acne oranti-eczema agent.
 21. The skin treatment composition according to claim20 wherein the agent comprises a drug selected from the group of: zincpyrithione, selenium suphide (selenium disulphide), and salicylic acidor salts thereof for the treatment of psoriasis, eczema or acne.
 22. Askin treatment composition comprising human serum albumin in an amounteffective to protect the skin from overexposure to the elements,environmental or metabolic, pharmaceutical or other pollutants,premature aging, and a suitable aqueous or alcohol-based gel or suitabletopical ointment, lotion, cream, balm or gel and a pharmaceuticallyacceptable vehicle, carrier or excipient.
 23. The composition accordingto claim 22 wherein the serum albumin comprises a recombinant serumalbumin.
 24. A method of protecting the skin from overexposure to theelements, environmental or metabolic, pharmaceutical or otherpollutants, premature aging comprising topically administering to ahuman or animal patient in need thereof the composition of claim 22 inan amount effective to achieve said protection.
 25. The skin treatmentcomposition according to claim 22 comprising human serum albumin andgelling agent.
 26. The composition of claim 25 wherein the gelling isselected from the group consisting of: hydroxyethylcelluose, carbomer, apolyethylene homopolymer, a polyethylene/vinyl acetate copolymer, apolyethylene/acrylic acid copolymer, azelaic acid, aloe vera, lecithin,thermoreversible polysaccarides, cetylhydroxyethyl cellulose.
 27. Theskin treatment composition according to claim 22 wherein the pH is in arange from 4.5 to 9.0.
 28. The skin treatment composition according toclaim 22 further comprising a sun or UV blocking agent.
 29. A sun or UVblocking composition comprising human serum albumin and a sun or UVblocking agent.
 30. The composition of claim 29 wherein the sun or UVblocking agent is selected from the group consisting of Aminobenzoicacid (PABA), Avobenzone, Cinoxate, Dioxybenzone, Ecamsule(terephthalylidene dicamphor sulfonic acid), Homosalate, Methylanthranilate, Octocrylene, Octyl methoxycinnamate, Octyl salicylate,Oxybenzone, Padimate O, Phenylbenzimidazole sulfonic acid,Sulisobenzone, Titanium dioxide, Trolamine salicylate and Zinc oxide.32. The composition of claim 29 further comprising a physiologicallyacceptable vehicle, excipient or carrier.
 33. The composition of claim32 wherein the vehicle, excipient or carrier is selected from the groupconsisting of: creams, balms, lotions, gels, and ointments effective forthe protection of the targeted skin areas.
 34. The composition of claim32 wherein the vehicle, excipient or carrier contains an ingredient isselected from the group consisting of Water, Ppg-15 Stearyl Ether,Oxidized Polyethylene, Stearyl Alcohol, Cetyl Betaine, Salicylic Acid,Distearyldimonium Chloride, Sodium Lauryl Sulfate, Cetyl Alcohol,Alcohol, Steareth-21, Cyclopentasiloxane, Niacinamide, Ethylene/AcrylicAcid Copolymer, Dimethicone Crosspolymer, Propylene Glycol, ButyleneGlycol, Panthenol, Peg-10 Dimethicone Crosspolymer, Tocopheryl AcetateCyclopentasiloxane, Polymethylsilsesquioxane, Stearyl Dimethicone,Palmitoyl Pentapeptide-3, Cetearyl Alcohol, Polysorbate 60, Helianthusannuus (sunflower) seed oil, Butyrospermum parkii (shea butter),Neopentyl Glycol Diheptonate, Isododecane, Glycerine, Ricinus communis(castor) seed oil, Hydrogenated castor oil, Beeswax, Copernica cerifera(carnauba) wax, Prunus amygdalus dulcis (sweet almond) oil,Caprylic/Capric triglycerides, Lanolin, Cannabis sativa seed oil,Glycine, Conjugated linoleic acid (CLA), Sodium Chloride, Potassiumphosphate, Isohexadecane, Petrolatum, Dihydroxyacetone, IsopropylIsostearate, Nylon. 12, Aluminum Starch, Octenylsuccinate, Dimethiconol,Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, BehenylAlcohol, Erythrulose, Squalane, Benzyl Alcohol, Glyceryl Stearate, PEG100 Stearate, Dicaprylyl Ether, Sodium Lactate, PEG 40 Stearate,Cyclopentasiloxane, Cyclohexasiloxane, Aluminum Starch, Mineral Oil,Phenoxyethanol, Panthenol, Stearic Acid, Dimethicone, Carbomer,Ceteareth-20, Sodium Hydroxide, Sodium Citrate, Methylparaben,Propylparaben, Citric Acid, Ethylparaben, Glyceryl Stearate SE,Octyldodecanol, Alcohol Denatured, Myristyl Alcohol, Creatine,Ubiquinone, Carbomer, 1 Methylhydantoin 2 Imide, C12 15 Alkyl Benzoate,Glyceryl Monostearate, Diazolidinyl, Trolamine, Edetate Disodium,Xanthan Gum, White Petrolatum USP, Ceteareth-20, Malic Acid, SodiumLactate, Xanthan Gum NE, C10 30 Cholesterol/Lanesterol, Hexyldecanol,Isopropyl Myristate, Glyceryl Caprate, Carthamus Tinctorius (Safflower)Seed Oil (Safflower), Styrene/Acrylates Copolymer, PEG 5 Soy Sterol, 1,2Hexanediol, Caprylyl Glycol, Ethylhexylglycerin, Triethanolamine, Grapeseed oil, corn oil, coconut oil, olive oil, sodium palmitate,polyethylene glycols (PEG), Candelilla wax, Soy wax, bees wax, petroleumbased wax, Lecithin Gel(PLO), PEG-100 Polydimethylsiloxane, emulsifyingwax, cyclomethicone, lemon oil, avocado oil, glycerin, vitamin C,vitamin. D, Polylysine epsilon, propylparaben, flax seed oil, cod liveroil, petrolatum, and lanolin.
 35. The composition according to claim 22wherein recombinant serum albumin is added to solution containing atleast water, Cetearyl Alcohol and Polysorbate
 60. 36. The compositionaccording to claim 22 wherein the serum albumin comprises a serumalbumin that has at least a one-amino acid truncation at its n-terminalend.
 37. A method of treating the skin comprising topically applying thecomposition of claim 22 to skin in an amount effective for protectingtargeted areas of the skin against environmental factors.
 38. The skintreatment composition according to claim 22 comprising 1-90 mg/ml humanserum albumin in a 1-90% alcohol solution.
 39. A hypoallergenic skinprotecting composition comprising 1 to 90 mg/ml recombinant human serumalbumin in a 1 to 90% alcohol gel or solution.
 40. The compositionaccording to claim 22 wherein the serum albumin in the alcohol gel orsolution is at a concentration in the range of about 1 to 250 mg/ml. 41.A method of protecting the skin against extreme environmental factorscomprising applying to said skin the composition of claim 22 in anamount effective to protect the targeted skin areas.
 42. A skintreatment composition according to claim 29 comprising 1-90 mg/ml humanserum albumin in a 1-90% alcohol solution.
 43. A hypoallergenic skinprotecting composition comprising 1 to 90 mg/ml of a modified humanserum albumin that has at least one mutation at its n-terminal endsufficient to cause steric hindrance at the binding region VI andthereby reduce or eliminate the albumin's affinity to trace metals, in a1-90% alcohol solution.
 44. The skin protecting composition according toclaim 43 comprising 1-60 mg/ml human serum albumin in a 5-70% alcoholgel or solution.
 45. The skin protecting composition according to claim43 further comprising a carbomer in an amount effective to form analcohol or water-based gel solution.
 46. The skin treatment compositionaccording to claim 43 wherein the pH is in a range from 4.5 to 9.0. 47.A skin treatment composition comprising human serum albumin in an amounteffective to enhance the sanitization of skin for a group consisting ofpersonal hygienic, pre or post surgical, or wound treatment purposes anda suitable aqueous or alcohol-based gel or topical ointment and one ormore suitable antimicrobial agents, vehicles, carriers or excipients.48. A method of preparing the skin for surgical incision comprisingtopically administering serum albumin with an antimicrobial in adermatological agent, vehicle, carrier or excipient in an amountaffective to sanitize the targeted skin areas.
 49. A method of treatingskin wounds, bed sores or damaged skin comprising applying to said skinthe composition of claim 43 in an amount effective to sanitize the woundsurface.
 50. The composition according to claim 43 wherein the albuminis recombinant human serum albumin.
 51. The skin treatment compositionaccording to claim 43 comprising human serum albumin and gelling agent.52. The skin treatment composition according to claim 51 wherein thegelling is selected from the group consisting of: hydroxyethylcelluose,carbomer, a polyethylene homopolymer, a polyethylene/vinyl acetatecopolymer, a polyethylene/acrylic acid copolymer, azelaic acid, aloevera, lecithin, thermoreversible polysaccarides, cetylhydroxyethylcellulose.
 53. The skin treatment composition according to claim 43comprising recombinant human serum albumin and an anti-microbial. 54.The composition of claim 53 wherein the anti-microbial is selected fromthe group consisting of: clindamycin, erythromycin, tetracycline,benzoyl peroxide, Silver sulfaldazine, tetracycline, sulfacetamidesodium/sulfur, bacitracin, polymyxin B, penicillin, amoxicillin,retpamulin, mupirocin, mafenide, sulfamethoxazole, trimethoprim,neomycin, sulfonamide, melocyclin, benzalkoniumchloride, accutane,doxycycline, benzoyl peroxide, human lysozyme, hen egg white lysozyme,chalorapsis lysozyme, acetic acid, ammonia, ethanol, isopropyl alcohol,phenoxyethanol, triclocarban.
 55. An eye treating composition comprisinghuman serum albumin in an amount effective to lubricate and/or promotethe healing of eye after surgical or accidental trauma and a vehicle,excipient or carrier suitable for use in the eye.
 56. An eye treatmentcomposition according to claim 55 wherein the human serum albumin isrecombinant.
 57. An eye treatment composition according to claim 55further comprising an anti-microbial agent.
 58. A skin treatmentcomposition comprising of human serum albumin in an amount effective tobe used in pharmaceutical compounding bases, such as creams, oils,lotions, gels or gel-based ointments, balms or any other form that issuitable for administration to skin which promotes dissolving,delivering, and/or protecting pharmaceutically active ingredients.